Inpatient and Outpatient Balloon Catheter Cervical Ripening

A Comparison Between Inpatient and Outpatient Balloon Catheter Cervical Ripening: A Prospective Randomized Controlled Trial

Sponsors

Lead Sponsor: National University of Malaysia

Source National University of Malaysia
Brief Summary

A randomised controlled trial comparing cervical ripening using foley catheter as in- or outpatient setting.

Detailed Description

The study evaluated the efficacy and safety of outpatient versus inpatient Foley catheter cervical ripening and patients' satisfaction. Sixty low-risk women were randomized to outpatient and inpatient management of intracervical Foley catheter digital insertion. The outpatient group was provided with verbal and written 24-hours contact information and instructions. Both groups were reassessed the next morning unless labor had begun or the catheter had dropped off.

Overall Status Completed
Start Date August 1, 2017
Completion Date May 31, 2018
Primary Completion Date May 31, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Caesarean section rate From the time of recruitment until delivery
Neonatal sepsis From birth up to 30 days
Secondary Outcome
Measure Time Frame
Maternal age At the time of recruitment
Ethnicity At the time of recruitment
Education level At the time of recruitment
Occupation At the time of recruitment
Pre-pregnancy maternal body mass index At the time of recruitment
Parity At the time of recruitment
Gestation at recruitment At the time of recruitment
Indication At the time of recruitment
Bishop score pre-induction Pre-intervention
Bishop score at second assessment From insertion of Foley catheter until labour established or the following morning
Management at second assessment At time of recruitment until delivery
Duration from induction until favourable Bishop score At time of recruitment until delivery
Augmentation with oxytocin At time of recruitment until delivery
Duration of oxytocin use At time of recruitment until delivery
Duration from amniotomy until delivery At time of recruitment until delivery
Duration from induction until delivery At time of recruitment until delivery
Delivery within 24 hours At time of recruitment until delivery
Duration of inpatient stay At time of recruitment until delivery
Total blood loss At the time of delivery
Intrapartum pyrexia At the time of delivery
Primary postpartum haemorrhage Immediately at delivery up to 42 days
Birth weight At the time of delivery
Arterial cord blood acidity or alkalinity At the time of delivery
Neonatal white cell count At the time of delivery
Neonatal C-reactive protein At the time of delivery
Discomfort with foley catheter At the time of recruitment until active phase of labour
Ability to cope with discomfort At the time of recruitment until active phase of labour
Intention to use the method again Through study completion until delivery
Feeling alone during induction At the time of recruitment until delivery
Duration of sleep At the time of recruitment until delivery
Able to rest and relax At the time of recruitment until delivery
Feeling of unsafe during cervical ripening At the time of recruitment until active phase of labour
Embarrassed by the method At the time of recruitment until active phase of labour
Enrollment 60
Condition
Intervention

Intervention Type: Device

Intervention Name: Foley catheter cervical ripening

Description: Participants were assessed when labour was established or the following morning.

Eligibility

Criteria:

Inclusion Criteria:

- singleton

- gestational age beyond 37 weeks

- cephalic presentation

- intact membranes

- Bishop score less than 6

- lives within 10km from National University Malaysia Medical Centre or able to reach within 30 minutes

- readily available transport

Exclusion Criteria:

- intrauterine death

- intrauterine fetal growth restriction

- estimated fetal weight more than 4000gram

- fetal anomalies

- abnormal pre-induction cardiotocograph

- non-vertex presentation

- unstable lie

- sepsis

- hypertension

- allergy to latex

- previous uterine scar

- history of antepartum haemorrhage

- parity of 6 and more

- placenta praevia

- suspected cephalopelvic disproportion

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: UKM Medical Centre
Location Countries

Malaysia

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: National University of Malaysia

Investigator Full Name: Rahana Abd Rahman

Investigator Title: Co-primary investigator

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Foley catheter inpatient

Type: Active Comparator

Description: Participants had intracervical ripening with foley catheter after admission into the ward.

Label: Foley catheter outpatient

Type: Active Comparator

Description: Participants had intracervical ripening with foley catheter and allowed home.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: The patients were randomised to cervical ripening with foley catheter as inpatient or outpatient setting.

Primary Purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov